Sources: Ortho Tri-Cyclen [package insert] (13);
Estrostep Fe [package insert] (14); Yaz [package insert].
TABLE FDA-approved estrogen-progestin contraceptives for the treatment of acne Brand name Generic name
Estrostep Norethindrone acetate-ethinyl estradiol plus ferrous fumarate Ortho Tri-Cyclen Norgestimate-ethinyl estradiol Yaz Drospirenone-ethinyl estradiol BeYaz Drospirenone-ethinyl estradiol plus levomefolate
OCPs with FDA approval for the treatment of acne include
Estrostep Fe (norethindrone/ethinyl estradiol [EE]), Ortho Tricyclen (norgestimate/EE), and Yasmin and Beyaz (drospirenone/EE).
Four are approved for this indication: Ortho Tri-Cyclen,
Estrostep, YAZ, and Beyaz.
But since at least 1995, research has shown that these newer pills double the blood-clot risk of earlier, "second generation" pills, such as TriNessa and
Estrostep. In 2007, the consumer group Public Citizen petitioned the FDA to ban third-generation pills.
Ortho Tri-Cyclen (norgestimate/ethinyl estradiol) and
Estrostep (norethindrone acetate/ethinyl estradiol) have been approved by the Food and Drug Administration for the treatment of acne.
The group counts contraceptives Ovcon and
Estrostep among its brands.
The group counts contraceptives Ovcon and
Estrostep among its brands as well as combination hormone therapy treatment femhrt and Sarafem.
Revenues from its continuing operations were up 13 per cent to $113.9 million, with strong growth in sales of oral contraceptive profits via Ovcon and
Estrostep.
Drug Daily Dosage norgestimate and ethinyl estradiol 180-250 [micro]g (Ortho Tri-Cyclen) norgestimate and 35 [micro]g ethinyl estradiol norethindrone acetate and 1 mg norethindrone acetate ethinyl estradiol (
Estrostep) and 20-35 [micro]g ethinyl estradiol Ievonorgestrel and ethinyl 100 [micro]g levonorgestrel estradiol (Alesse) and 20 [micro]g ethinyl estradiol Drug Cost/Day * norgestimate and ethinyl estradiol $1.11 (Ortho Tri-Cyclen) norethindrone acetate and $1.18 ethinyl estradiol (
Estrostep) Ievonorgestrel and ethinyl $1.13 estradiol (Alesse) Drug Comment ** norgestimate and ethinyl estradiol First birth conrol pill with (Ortho Tri-Cyclen) FDA approval for acne.
*
Estrostep (norethindrone acetate-ethinyl estradiol plus ferrous fumarate)
In the United States, ethinyl estradiol/norethindrone acetate (
Estrostep, Warner Chilcott); drospirenone/ethinyl estradiol (Yaz, Bayer); and ethinyl estradiol / norgestimate (Ortho Tri-Cyclen, Ortho McNeil Janssen) are FDA-approved for acne treatment "and others with estrogen may be effective."